# K040053: Precision VPS Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Discus Dental, Inc.
- Decided: Mar 25, 2004 after 73 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943574 (1994). 3 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021416: Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material, Dentsply Intl. (2002) Summary page 2.
- K030318: P2 Polyether, Heraeus Kulzer, Inc. (2003) Summary page 2.

## Most influential descendants
- K062450: D-Spect Cardiac Scanner System (2006), 14 descendants of its own
- K072468: Modification to D-Spect Cardiac Scanner System (2007), 10 descendants of its own
- K110507: Cardiac Scanner and Processing System (2011), 9 descendants of its own
- K052090: Splash! Impression Material Device (2005), 7 descendants of its own
- K161740: D-SPECT Scanner, D-SPECT L Scanner (2016), 5 descendants of its own

## Indications for use
Precision VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums.

Source page: https://510kreport.com/device/K040053
Methodology: https://510kreport.com/methodology